Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT04554303
Eligibility Criteria:
Inclusion Criteria:
1. Patients with essential hypertension and diagnosed with stage 1-2 hypertension in accordance with the 2019 Korean Society of Hypertension criteria (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg)
2. Where a subject and his/her spouse (partner) have agreed to use medically acceptable contraceptives in the following during participation in this clinical study:
* Use of intrauterine device with proven failure rate of pregnancy;
* Simultaneous use of blocking contraception and spermicide;
* Has had a vasectomy;
* Has had a salpingectomy, tubal ligation, or hysterectomy;
3. Those who have made voluntary decisions to participate in this clinical study and have consented to the Informed Consent Form in writing;
4. Those who are able to understand and follow instructions and participate throughout the entire clinical study
Exclusion Criteria:
1. Patients with uncontrolled, high-risk hypertension (SBP≥180mm Hg and DBP≥110mm Hg);
2. Those who have a history of secondary hypertension and any history of suspected secondary hypertension (aortic congestion, hyperaldosteronism, renal artery stenosis, Cushing's disease, chromaffinoma, polycystic renal disease, etc.);
3. Those who fall under one or more of the following items that may cause edema without underlying diseases:
* Those who have been diagnosed with myocardial infarction or heart failure within 6 months of screening;
* Those who have been diagnosed with a cerebrovascular accident (CVA) within 6 months of screening;
* Patients with renal failure requiring dialysis or those with edema caused by renal dysfunction (renal salt retention);
* Those who have uncontrolled diabetes (HbA1c\> 10.0%) or diabetic edema;
* Patients with severe liver dysfunction or edema caused by liver disease (cirrhosis);
* Other patients with hypothyroidism, proteinuria, and problems at the joint or ankle joint
4. Those who have cerebrovascular disease, unstable angina, or transient ischemic attack, or those who have had coronary artery bypass graft or coronary angioplasty;
5. Patients who may develop edema by concomitant drugs at screening:
* Drugs that constrict intrarenal blood vessels (e.g. nonsteroidal anti-inflammatory drugs, cyclosporine, etc.);
* Drugs that dilate arterioles (e.g. vasodilators, etc.);
* Drugs that increase sodium reabsorption in the kidneys (e.g. steroids, etc.);
* Drugs that damage capillaries (e.g. interleukin-2, etc.);
* Glitazone-based drugs for diabetes
6. Those who show hypersensitive reaction\* to the investigational product;
7. Those who are taking the following drugs that may cause drug interactions:
* Drugs that may change the plasma concentration of amlodipine \[e.g. CYP3A4 inducers (e.g. rifampicin, St. John's wort (Hypericum perforatum), etc.);
* Drugs that may increase the antihypertensive action \[e.g. other antihypertensives (calcium channel blockers, beta blockers, ACEi, ARB, alpha blockers, diuretics, nitroglycerin), tricyclic antidepressants (amitriptyline, desipramine, imipramine, nortriptyline, protriptyline, trimipramine, etc.), nitrate formulation, baclofen, pioglitazone, sildenafil, etc.\];
* Systemic corticosteroids (fluocinolone, triamcinolone), etc.: Local application allowed;
* Drugs that may increase the inhibitory action of muscle contraction \[e.g. antiarrhythmics (amiodarone, quinidine, etc.);
* Drugs that may cause ventricular spasms (e.g. intravenous administration of dantrolene and verapamil);
* Drugs that may increase the risk of hypotension \[e.g. CYP3A4 inhibitors (clarithromycin), etc.\]
8. Patients in a state of chronic inflammation requiring chronic anti-inflammatory treatment;
9. Those who have participated in other interventional clinical studies within 6 months of screening;
10. Those who have been diagnosed as having malignant tumors within 5 years of screening;
11. Those who showed clinically significant abnormal results in electrocardiogram and laboratory tests at screening;
12. Those who are pregnant or lactating, or have been confirmed as being pregnant through the Urine HCG test;
13. Those who have been judged to be inappropriate to participate in the clinical study by the principal investigator or subinvestigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04554303
Study Brief:
Protocol Section:
NCT04554303